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Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)

12. juli 2026 opdateret af: ORI Community and Evaluation Services
This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. Participants will be randomly assigned to one of two conditions. In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in. These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing. In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Oregon
      • Springfield, Oregon, Forenede Stater, 97477
        • Rekruttering
        • Oregon Research Institute Community and Evaluation Services
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Ages 18-70 years
  • BMI of 25-50 kg/m2
  • Current weight is 3% lower than their highest weight in the past 3 years
  • Desire to maintain their weight or lose more
  • Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
  • Smartphone and Internet access
  • Successful completion of all enrollment procedures
  • Ability to attend a workshop(s) on a Monday or Tuesday evening

Exclusion Criteria:

  • History of bariatric surgery
  • History of being diagnosed with an eating disorder
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
  • Enrolled in another formal weight loss/weight maintenance program
  • Currently taking a GLP-1 medication.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: JITAI Condition
Participants in this condition will receive a 6-month weight loss maintenance intervention that uses mindfulness, acceptance, and self-compassion strategies to respond to weight regain.
Adfærdsmæssigt: JITAI Combined with psychological intervention
For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm). Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections). They will take approximately 1-10 minutes. Participants will also attend an introductory workshop, during which they will receive the instructions weigh daily, learn the importance of quickly responding to weight regain, and be introduced to MASC strategies. They will also attend two booster workshops during the 6-month period.
Aktiv komparator: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
Adfærdsmæssigt: Active Control
For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles. Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
State negative affect
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State shame
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State Motivation
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State Self-Efficacy
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Current confidence in the effectiveness of weight control behaviors
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State self-compassion
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State mindfulness
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State acceptance
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Self-serving interpretation of weight gain
Tidsramme: Whenever participants regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
Whenever participants regain weight during the 6 month study period
Daily Calorie Tracking (Yes/No)
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Daily MVPA
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Likelihood of weighing in the following day
Tidsramme: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Weight change
Tidsramme: End of treatment (6 months after baseline)
Using participants' weights from a wireless scale, we will calculate their percent weight change from the beginning to the end of the study period.
End of treatment (6 months after baseline)
Intervention acceptability
Tidsramme: End of treatment (6 months after baseline)
We will record the percent of participants who indicate that they are "satisfied" or "very satisfied" with the program on an anonymous survey that they complete during their individual interview.
End of treatment (6 months after baseline)
Calorie Tracking Frequency
Tidsramme: 6 months (duration of study period)
The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
6 months (duration of study period)
Average Weekly MVPA
Tidsramme: 6 months (duration of study period)
Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
6 months (duration of study period)
Frequency of Weighing In
Tidsramme: 6 months (duration of study period)
Total number of days that participants weighed themselves on a wireless smart scale during the study period.
6 months (duration of study period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mindfulness (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
Participants will self-report their mindfulness using the present moment awareness subscale of the Philadelphia Mindfulness Scale.
Mid-Treatment (3 months after baseline)
Acceptance (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
Participants will self-report their mindful acceptance using the acceptance subscale of the Philadelphia Mindfulness Scale.
Mid-Treatment (3 months after baseline)
Self-compassion (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
Participants will report their self-compassion using the State Self-Compassion Scale.
Mid-Treatment (3 months after baseline)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ORI Community and Evaluation Services

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

12. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K01HL172254 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Overvægt eller fedme

Kliniske forsøg med JITAI Combined with psychological intervention

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